Over-the-counter drug · OTC MONOGRAPH DRUG
Sinus Congestion and Pain Severe NDC 49035-527
acetaminophen, guaifenesin and phenylephrine hcl · Acetaminophen 325 mg/1 + 2 more ingredients · Tablet, Film coated · Oral · Wal-Mart Stores Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 49035-527-08 | 4903505270849035052708 | 2 BLISTER PACK in 1 CARTON (49035-527-08) / 12 TABLET, FILM COATED in 1 BLISTER PACKMarketed from Aug 6, 2005 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Sinus Congestion and Pain SevereSuffix: Severe
- Generic name (nonproprietary)
- acetaminophen, guaifenesin and phenylephrine hcl
- Active ingredients
- Acetaminophen — 325 mg/1Guaifenesin — 200 mg/1Phenylephrine hydrochloride — 5 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Wal-Mart Stores IncNDC labeler code 49035
- Product type
- Over-the-counter drug
- Marketing category
- OTC monograph drugApplication M 012
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic alpha1-Agonists (Mechanism)Decreased Respiratory Secretion Viscosity (Physiologic effect)Increased Respiratory Secretions (Physiologic effect)
- Identifiers
- Product ID 49035-527_dbfccbf6-2f75-4679-824d-f8cdfd7b7319SPL ID dbfccbf6-2f75-4679-824d-f8cdfd7b7319SPL set ID f51d1d52-39c2-4259-8b30-f9ac21edb265RxCUI 1243679UNII 362O9ITL9D, 495W7451VQ, 04JA59TNSJUPC 0681131187206
- Pharmacologic class
- Expectorant; alpha-1 Adrenergic Agonist
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N449035052708followed by a unit qualifier and the quantityPackage 49035-0527-08. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
Uses temporarily relieves these symptoms associated with hay fever or other respiratory allergies, and the common cold: headache minor aches and pains nasal congestion sinus congestion and pressure helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive temporarily reduces fever
Excerpt only. Read the full label for complete information.
About NDC 49035-527
- What is NDC 49035-527?
- 49035-527 is the product NDC for Sinus Congestion and Pain Severe, Acetaminophen 325 mg/1 + 2 more ingredients tablet, film coated, listed with the FDA by Wal-Mart Stores Inc. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Sinus Congestion and Pain Severe (Acetaminophen, Guaifenesin and Phenylephrine HCl).
- What is the active ingredient?
- Acetaminophen, Guaifenesin, Phenylephrine hydrochloride.
- Who is the labeler?
- Wal-Mart Stores Inc, NDC labeler code 49035. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Sinus Congestion and Pain Severe?
- 1 other product NDC are listed under this name. See all Sinus Congestion and Pain Severe NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Sinus Congestion and Pain Severe products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Sinus Congestion and Pain Severeacetaminophen, guaifenesin, and phenylephrine hydrochloride | Guaifenesin 200 mg/1 + 2 more ingredients | Tablet, CoatedOral | TopCare | 36800-505 | 36800-0505-05 |
Other NDCs under M 012
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Cough Reliefdextromethorphan hydrobromide | Dextromethorphan hydrobromide 15 mg/1 | Capsule, Liquid filledOral | Advanced Rx LLC | 80513-311 |
| TARGET Multi Symptom Flu Reliefacetaminophen, dextromethorphan hbr, and acetaminophen, chlorpheniramine maleate, dextromethorphan hbr | — | Kit | TARGET CORPORATION | 82442-559 |
| Geri-Dryl allergy reliefdiphenhydramine hcl | Diphenhydramine hydrochloride 25 mg/1 | Tablet, CoatedOral | VerityRx | 83939-0683 |
| Multi Symptom Cold and Multi Symptom Nighttime Cold Childrensdextromethorphan hbr, guaifenesin, phenylephrine hci, acetaminophen, diphenhydramine hci, phenylephrine hci | — | Kit | TARGET Corporation | 11673-420 |
| Welmedix HomeCare PRO Extra Strength Rapid Rash Reliefpetrolatum, zinc oxide | Petrolatum 49 g/100g; Zinc oxide 15 g/100g | CreamTopical | Welmedix LLC | 24330-410 |
| topcare nite time cold and fluacetaminophen, dextromethorphan hbr, doxylamine succinate | Acetaminophen 325 mg/1 + 2 more ingredients | Capsule, Liquid filledOral | Topco Associates LLC | 36800-143 |
| Allergy Childrensdiphenhydramine hydrochloride | Diphenhydramine hydrochloride 12.5 mg/5mL | LiquidOral | H E B | 37808-012 |
| Mucus Relief Cough Childrensdextromethorphan hbr, guaifensin | Dextromethorphan hydrobromide 5 mg/5mL; Guaifenesin 100 mg/5mL | LiquidOral | H E B | 37808-594 |
| Sunmark Chest Congestion Relief DM DMdextromethorphan hydrobromide / guaifenesin | Dextromethorphan hydrobromide 20 mg/1; Guaifenesin 400 mg/1 | TabletOral | Strategic Sourcing Services LLC | 49348-728 |
| Dual Action Honey Lemon Cough Suppressant Oral Anestheticmenthol | Menthol 8.3 mg/1 | LozengeOral | Ricola Ag | 54305-323 |
| Discount drug mart Extra Moisturizingoxymetazoline hydrochloride | Oxymetazoline hydrochloride .05 g/100mL | SprayNasal | DISCOUNT DRUG MART | 53943-720 |
| Mucus Reliefguaifenesin | Guaifenesin 400 mg/1 | TabletOral | Geri-Care Pharmaceuticals, Corp | 57896-714 |
| Robitussin Maximum Strength Severe Multi-Symptom Cough Cold Flu Nighttimeacetaminophen, diphenhydramine hcl | Acetaminophen 650 mg/20mL; Diphenhydramine hydrochloride 25 mg/20mL | LiquidOral | Haleon US Holdings LLC | 0031-0101 |
| Throat Comfort Orange Mint Cinnamon Dropsmenthol | Menthol 3.6 mg/1 | LozengeOral | Ricola USA Inc. | 63667-342 |
| Non-Drowsy Sinus Severe, Circle Kacetaminophen, guaifenesin, phenylephrine hcl caplet, film-coated | Guaifenesin 200 mg/1 + 2 more ingredients | Tablet, Film coatedOral | Lil' Drug Store products, Inc. | 66715-5632 |
| COLD, Flu and Sore Throatacetaminophen, guaifenesin, dextromethorphan hydrobromide, and phenylephrine hydrochloride | Acetaminophen 325 mg/1 + 3 more ingredients | Capsule, Liquid filledOral | Walgreens | 0363-9016 |
| Mucus Relief All in One Maximum Strengthacetaminophen, diphenhydramine hcl phenylephrine hcl | Acetaminophen 650 mg/20mL + 2 more ingredients | LiquidOral | Walgreens | 0363-9130 |
| Pyrilamine Maleate and Dextromethorphan Hydrobromide | Dextromethorphan hydrobromide 7.5 mg/5mL; Pyrilamine maleate 7.5 mg/5mL | LiquidOral | Westminster Pharmaceuticals, LLC | 69367-398 |
| Daytime Cold and Flu Relief Liquid Filled Softgelsacetaminophen, dextromethorphan hbr, phenylephrine hcl | Acetaminophen 325 mg/1 + 2 more ingredients | Capsule, Liquid filledOral | AptaPharma Inc. | 76281-604 |
| Cough Dropsmenthol | Menthol 5.8 mg/1 | PastilleOral | Topco Associates LLC | 76162-016 |
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